UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033783 |
|---|---|
| Receipt number | R000038538 |
| Scientific Title | muscle volume change by ICU-acquired weakness with/without high dose protein and electrical muscle stimulation |
| Date of disclosure of the study information | 2018/08/16 |
| Last modified on | 2021/02/16 13:15:03 |
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Basic information
Public title
muscle volume change by ICU-acquired weakness with/without high dose protein and electrical muscle stimulation
Acronym
protein dose and electrical muscle stimulation for ICU-AW
Scientific Title
muscle volume change by ICU-acquired weakness with/without high dose protein and electrical muscle stimulation
Scientific Title:Acronym
protein dose and electrical muscle stimulation for ICU-AW
Region
| Japan |
Condition
Condition
ICU-AW
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the efficacy of protein dose and electrical muscle stimulation for ICU-AW
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
femoral muscle volume change (evaluated by computed tomography)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
In the first period, enteral nutrition after admission is performed by high protein group: Peptamen Intense for ten days.
Interventions/Control_2
In the first period, enteral nutrition after admission is performed by normal group: Glucerna REX for ten days.
Interventions/Control_3
In the latter period, all patients are treated with electrical muscle stimulation, and enteral nutrition after admission is performed by high protein group: Peptamen Intense for ten days.
Interventions/Control_4
In the latter period, all patients are treated with electrical muscle stimulation, and enteral nutrition after admission is performed by normal group: Glucerna REX for ten days.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 admission to ICU
2 age >=20
3 able to perform enteral nutrition
4 get the informed consent
Key exclusion criteria
1 age <20
2 young female who can get pregnant
3 can not get the informed consent
4 the other inadequate patients
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Nakamura |
Organization
Hitachi General Hospital
Division name
Emergency and Critical Care Medicine
Zip code
3170077
Address
2-1-1 Jonancho Hitachi Ibaraki Japan
TEL
+81294231111
mamashockpapashock@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Nakamura |
Organization
Hitachi General Hospital
Division name
Emergency and Critical Care Medicine
Zip code
3170077
Address
2-1-1 Jonancho Hitachi Ibaraki Japan
TEL
+81294231111
Homepage URL
mamashockpapashock@yahoo.co.jp
Sponsor or person
Institute
Hitachi General Hospital
Emergency and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
no funding source
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hitachi General Hospital
Address
2-1-1 Jonancho Hitachi Ibraki Japan
Tel
0294231111
mamashockpapashock@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
134
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 16 | Day |
Last modified on
| 2021 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038538
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
